This invention relates to a port and closure assembly. In particular, the present invention relates to an integrally molded port closure for sealing a port of a solution container.
Ports are utilized to access material packaged within a container. As used herein, the term ports includes, without limitation, fitments, valves and other means for accessing a container. In the medical industry, parenteral and peritoneal dialysis solutions are packaged in flexible containers that are accessed via a port. An example of such a flexible container is the VIAFLEX.RTM. collapsible plastic container sold by Travenol Laboratories, Inc., of Deerfield, Ill.
In the medical industry particularly, and in other applications, it is essential that the solution in the container is maintained and extracted under sterile conditions. This requires not only that the container and its contents be in a sterile sealed condition at the time of receipt by the user, but also that no contamination of the contents occur when the container is opened by a physician, nurse, or medical technician prior to use. The problem of maintaining sterility is particularly acute at the port of the container.
Typically, the port comprises a tubular structure with an inner bore. Located within the inner bore is a needle pierceable wall that provides a barrier between the fluid contained within the container and the outside environment. Usually, pointed means that pierce the pierceable wall are used to access the fluid and thereby the container. To guard against contamination at the port, closures are utilized for covering the tubular bore of the port.
Some of the problems experienced by the prior art closures are the fact that they do not provide a hermetic seal, are difficult to remove, and do not lend themselves to high speed production. Typically, the process of creating the closure and port assembly includes three steps: molding the port; creating a closure; and fitting the closure on the port. Unless these three steps are performed under aseptic conditions, it is also necessary to sterilize the unit once it is constructed.
Moreover, the closures of the prior art have not provided a satisfactory tamper evident closure. Because it is critical that a sterile environment is maintained, it is advantageous if the closure and port cooperate to provide some means for alerting the user that the closure has been opened and accordingly the aseptic environment violated.
Another problem with prior art closures is the fact that typically they can not be utilized to identify the solution container once the closure is opened. To identify the type of solution contained in the container closures may be color coded. But, once the closure is removed from the port, the container is no longer coded.
Thus, there is a need for a port and closure assembly that overcomes the disadvantages of the prior art.